Alerts added to cholesterol-lowering drugs

U.S. health regulators are adding warnings to the labels of widely used cholesterol-lowering drugs to say they might raise levels of blood sugar and could cause memory loss.

U.S. health regulators are adding warnings to the labels of widely used cholesterol-lowering drugs to say they might raise levels of blood sugar and could cause memory loss.

The Food and Drug Administration announced yesterday the changes to the safety information on the labels of statins such as Pfizer Inc.’s Lipitor, AstraZeneca’s Crestor and Merck & Co.’s Zocor, which are taken by tens of millions of people.

Statins have been shown to significantly reduce the risk of heart attack and heart disease, and the FDA said the new information should not scare people into stopping taking the drugs.

“The value of statins in preventing heart disease has been clearly established,” Amy Egan, deputy director for safety in the FDA’s Division of Metabolism and Endocrinology Products, said in a statement. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

Lipitor, which became available late last year in generic form as atorvastatin, is the world’s all-time biggest-selling prescription medicine, with cumulative sales in excess of $130 billion.

Last year, more than 20?million Americans were taking some form of statin, according to IMS Health.

“These are nuances, tiny little tweaks to the label, and the bigger picture doesn’t change,” said Steven Nissen, chief of cardiology at the Cleveland Clinic. “There are few drugs that have saved as many lives as statins, and we don’t want to throw the baby out with the bath water here.

“If you have heart disease, you probably should be on a statin. If you’re at high risk, a statin may be warranted. But we don’t think these drugs should be put in the water supply,” Nissen said.

Asked what prompted the label changes, FDA spokeswoman Erica Jefferson said they were based on the agency’s review of medical literature, clinical-trial data and reports of adverse events.

“I wouldn’t point to any one thing,” she said. “We’ve been looking at all the information for some time. It’s part of our ongoing surveillance.”

The FDA said it was aware of studies in which some patients taking statins might have a small increased risk of higher blood-sugar levels and of being diagnosed with type 2 diabetes.

The statin labels also will now reflect reports of certain cognitive effects such as memory loss and confusion experienced by some patients taking the drugs, the agency said. It said those reports generally have not been serious and that the symptoms were reversed by stopping use of the statin.

“We have known for three or four years that statins slightly increase blood sugar,” Nissen said. “The fact that the blood sugar went up a little bit did not diminish the effectiveness of the statins in reducing (heart) risk for patients.”

The elevated diabetes risk cropped up in a 2008 Crestor study of nearly 18,000 patients. A separate study published in the Lancet medical journal in 2010 found that statins can raise the risk of diabetes by 9 percent.

Reports of the memory-loss issue were more anecdotal, the FDA said. There is no proof that the problem is caused by statins, but the agency wanted people to be aware of the possibility.

One safety warning long associated with this class of medicines will be reversed, the FDA said. Patients taking statins will no longer need periodic monitoring of liver enzymes, since cases of serious liver injury are rare and unpredictable in individual patients.

Other statins, most of which are available as generics, include Livalo, Mevacor, Pravachol and Altoprev. Some combination medicines, such as Merck’s Vytorin and Abbott Laboratories’ Simcor, also include statins.

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